also available in dutch
Bunnik, the Netherlands, April 8th, 2005
AM-Pharma Holding B.V., a Dutch private biopharmaceutical company based in Bunnik, has been granted a € 2,0 million subsidy for the development of her lead compound hLF1-11 (a human Lactoferrin derived peptide). This program develops hLF1-11 as an effective treatment of life threatening systemic fungal infections. The subsidy has been granted by SenterNovem, the agency of the Ministry of Economic Affairs which stimulates bilateral cooperation between commercial life science companies and knowledge institutes like Universities.
In collaboration with scientists at the Universities of Leiden, Utrecht and Nijmegen, AM-Pharma will proceed her preclinical and clinical development program, leading to further knowledge on mechanism of action, and clinical evidence for safety and efficacy in the projected therapeutic area.
Robert Friesen, VP Research & Preclinical Development, responsible for the SenterNovem subsidy application and coordination of the complete program explains: ”With this subsidy AM-Pharma can form a balanced consortium with experts in relevant fields of research and development. With this consortium AM-Pharma can rapidly develop its lead compound into a much needed effective and safe anti-infective for hemopoetic stem cell transplant patients. The research and development strength of this consortium will be used to establish a unique technology platform, generating several follow-up proprietary antimicrobial compounds.”
In a development program a number of antimicrobial peptides, including full length human lactoferrin and ubiquicidine, and small proprietary derived peptides thereof, have been tested for antimicrobial activity. The lead compound emanating from this research, hLF1-11, consists of the first 11 amino acids of the N-terminus of the parent molecule. The antimicrobial activity of hLF1-11 could be demonstrated in vivo using well-established mouse, rat and rabbit models, including muscle, kidney and lung infections. In vivo, hLF1-11 displayed a much stronger antimicrobial activity against all tested fungal and bacterial strains than the full length lactoferrin.
In vivo efficacy, both in an Candida and in an Aspergillus infection models have been established, indicated by a significant reduction of viable Candida or an improved survival rate, respectively. On the basis of these and other excellent data AM-Pharma is targeting the prevention of infections in patients undergoing stem cell transplantation, especially allogeneic. In this population, postoperative rates of severe infection and mortality are high, which make it a highly suitable population for establishing early clinical proof-of-principle, and a fast track regulatory approval and/or Orphan Drug Designation. Subsequently, the lead compound will be developed as a systemic antifungal. Also AM-Pharma is actively pursuing the development of follow-up compounds of hLF1-11.
Systemic infections with Aspergillus are particularly prevalent in neutropenic patients. Standard care, including prophylactic antibiotics and antifungals, fails to prevent death in one-half to two-thirds of patients. Such patients are also often suffering from bacterial or viral infections, as well as systemic candidiasis. The described broad spectrum of our antimicrobial peptides particularly in neutropenic animals could make them ideal candidates for the prophylaxis of several different infections in neutropenic patients. Such an application would not preempt the use of specific antimicrobial therapeutics, because of observed synergistic effects and observed absence of resistance / cross resistance.
Bart Bierman, Chief Executive Officer of AM-Pharma said: “We are excited about this subsidy. Further to our almost completed financing round, it will accelerate our efforts to bring a peptide to the antimicrobial market. The high medical need in patients with fungal, but also with bacterial infections, and the ever worsening problem of bacterial resistance against commonly used antibiotics, strongly support our diligence in completing the early clinical program, and to proceed with structuring further scientific evidence parallel to a solid technology platform.” We anticipate to finish phase I studies with hLF1-11 mid of this year and antibacterial phase IIa efficacy proof of concept end of 2006.
AM-Pharma is focused on the development of novel pharmaceutical compounds, derived from the innate human immune system. The resulting products are intended for the treatment of patients suffering from a variety of serious infectious diseases. Specifically, the company operates in the segments of LPS-mediated diseases and infections of fungal and bacterial origin, offering products that address unmet medical needs.
Bart Bierman, Chief Executive Officer
E-mail: info@am-pharma.com
Tel: +31 (0)30 2289222
Website: www.AM-Pharma.com